Cord blood transplantation with a specific conditioning regimen and post-transplant treatment
Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)
This study is testing a new way to use cord blood for transplants to see if a specific treatment can help prevent complications and improve recovery for patients receiving the transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | Fludarabine, cyclophosphamide |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT03802773 on ClinicalTrials.gov |
What this trial studies
This study evaluates the outcomes of cord blood transplantation using a myeloablative conditioning regimen combined with post-transplant cyclophosphamide for preventing graft-versus-host disease (GVHD). The primary focus is on assessing neutrophil and platelet engraftment, as well as CD4+ cell counts at day +100 post-transplant. Secondary objectives include measuring the incidence and severity of both acute and chronic GVHD. The study aims to provide insights into alternative approaches for T cell depletion in cord blood transplantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with specific hematological malignancies who are eligible for cord blood transplantation.
Not a fit: Patients with active infections such as HIV, acute hepatitis B, or acute hepatitis C will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve patient outcomes by enhancing immune recovery and reducing transplant-related complications.
How similar studies have performed: While there have been studies on cord blood transplantation, this specific approach with post-transplant cyclophosphamide is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: ≥ 18 ≤ 75 years old * CB unit transplantation (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA matched) * Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine * GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF * Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant. Exclusion Criteria: * Positive serologic markers for human immunodeficiency virus (HIV) * Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection
Where this trial is running
Roma, RM
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Rm, Italy (Recruiting)
Study contacts
- Principal investigator: Patrizia Chiusolo, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Andrea Bacigalupo, Prof.
- Email: andrea.bacigalupo@unicatt.it
- Phone: 0630154180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.